The Senior Ethics & Compliance Specialist/Regulatory Support Manager is a subject matter expert on FDA regulations, the university’s policies, processes, and standards. The Senior Specialist serves as leader within the Office of Ethics and Compliance (OEC) and serves as a resource to the greater university community; coordinates oversight and compliance activities with other units across UCSF; and communicates compliance obligations while assisting faculty and staff in translating compliance requirements and expectations into their daily work. The Senior Specialist also provides thought leadership on addressing evolving internal and external compliance concerns and changes in regulatory or policy requirements.
The Senior Specialist independently oversees, advises, and manages the activities of the Regulatory Support unit and the ClinicalTrials.gov unit within OEC. The Senior Specialist is responsible for effective functional area management, long-range planning for improvement of operational efficiencies and establishing strategic directions for comprehensive regulatory consultation and clinicaltrials.gov programs. The Senior Specialist manages daily operations of these two units, including the deployment of technology and web content to support and advance compliance services. The Senior Specialist also drives process enhancements and efficiencies and proposes and implements training of all relevant stakeholders. The Senior Specialist directly supervises the Regulatory Specialists.
This role requires the incumbent to also provide administrative, regulatory and policy support across all functional units within the Office of Ethics & Compliance (OEC), as needed. These functional units include Conflict of Interest in Research, Investigations Unit, Export Control, Research Integrity, and Regulatory Support.
The final salary and offer components are subject to additional approvals based on UC policy.
To see the salary range for this position (we recommend that you make a note of the job code and use that to look up): TCS Non-Academic Titles Search (https://tcs.ucop.edu/non-academic-titles)
Please note: An offer will take into consideration the experience of the final candidate AND the current salary level of individuals working at UCSF in a similar role.
For roles covered by a bargaining unit agreement, there will be specific rules about where a new hire would be placed on the range.
To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html
- Master’s degree or JD
- Professional certification(s) applicable to job responsibilities preferred
- Bachelor's degree in related area and / or equivalent experience / training
- Six years of practical experience in the application of FDA regulations, ethics and compliance policies, procedures, and programs in an institution of higher education
- Expert knowledge of the ethics and compliance profession, theories and systems of internal control, and professional compliance standards
- Ability to assume ownership of regulatory consultation, clinicaltrials.gov and drive best practices across the university
- Ability to gather, organize, analyze, and report on issues and recommendations that are complex in nature
- Excellent interpersonal skills to work independently with all levels of University personnel, including management and faculty, and to facilitate agreement on issues and corrective actions
- Ability to communicate complex information to all levels of management and administrators in a clear and concise manner both written and verbal
- Excellent skills in complex decision making on critical issues
- Excellent skills in presenting information in a relevant, thorough, and complete manner
